Sialic acids are a diverse family of monosaccharides widely expressed on glycoproteins, including biopharmaceuticals.
Sialic acid type and abundance affect protein half-life in the serum, immunogenicity, and activity. The most common sialic acid member found on glycoproteins is Neu5Ac (NANA). While NANA is found in both human and non-human cells, NGNA, which is hydroxylated derivate of NANA, is not found in human cells and is considered as immunogenic.
Sialic acid analysis is applicable to all stages of biopharmaceutical development and manufacturing processes including cell line and clone selection, upstream and downstream process development and manufacturing in-process control, batch consistency and release.
Sialic acid analysis is required by ICH Q6B guidelines for biopharmaceutical characterization.
Sialic acid residues are cleaved from the glycoprotein, labeled with the fluorescent dye DMB, and the labeled sialic acid residues are separated by reverse phase chromatography (RP-HPLC). The different sialic acid types are identified and quantified using standards.
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